Recall Z-1320-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
| Date | Aug 12, 2005 (initiated May 26, 2005) |
| Status | Terminated |
| Reason | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| Root cause | Other |
| Quantity | 19 |
| Distribution | Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc., Jul 10, 1996 |